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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name densitometer, bone
510(k) Number K041266
Device Name PEDIATRIC REFERENCE DATABASE
Applicant
HOLOGIC, INC.
35 CROSBY DR.
BEDFORD,  MA  01730
Applicant Contact ANA RANDALL
Correspondent
HOLOGIC, INC.
35 CROSBY DR.
BEDFORD,  MA  01730
Correspondent Contact ANA RANDALL
Regulation Number892.1170
Classification Product Code
KGI  
Date Received05/12/2004
Decision Date 08/11/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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